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NCT Number: NCT06234410

Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation

Cardiovascular disease (for example, heart attack, stroke, heart failure) is the commonest complication of kidney failure. Kidney transplantation reduces cardiovascular risk but cardiovascular disease remains the commonest cause of death in patients following transplantation.

Current strategies to assess patient's cardiovascular risk prior to kidney transplantation do not identify those at highest risk and do not improve outcomes.

This study will use a heart scan known as computed tomography coronary angiography (CTCA) to see whether this scan can identify patients at highest risk of future cardiovascular disease prior to transplantation. Studies have shown it is able to do this in patients with normal kidney function.

The aim of this study is to develop CTCA as an effective tool to risk stratify patients prior to kidney transplantation.

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Chronic Disease Coronary Artery Disease Coronary Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Kidney Transplant; Complications Male Urogenital Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Infirmary of Edinburgh, Edinburgh, Lothian, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has kidney failure and is on the waitlist for a kidney transplant
  • Age 16 years and over
  • Able to give informed consent

Exclusion criteria

  • Contraindication to CT scanning, including contrast allergy
  • Patients being considered for a simultaneous kidney-pancreas, kidney-liver and/or kidney-islet transplantation
  • Inability to give informed consent

Treatment and study plan

Computed tomography coronary angiography (CTCA)

Radiation

Single CTCA scan prior to kidney transplantation

Primary outcomes

  1. Number of participants who have either a myocardial infarction or cardiovascular death

    Time frame: From time of CTCA scan to 36- and 60-months follow-up

    The first event of myocardial infarction or cardiovascular death

Secondary outcomes

  1. Number of participants who have a fatal or non-fatal myocardial infarction

    Time frame: From time of CTCA scan to 36- and 60-months follow-up

    The first event of myocardial infarction (MI). MI will be defined according to the 4th Universal Definition of Myocardial Infarction.

  2. Number of participants who are hospitalised due to any cardiovascular event

    Time frame: From time of CTCA scan to 36- and 60-months follow-up

    Hospital admission due to any cardiovascular event (including myocardial infarction, heart failure, stroke, or any other cardiovascular disease)

  3. Number of participants who die (all-cause death)

    Time frame: From time of CTCA scan to 36- and 60-months follow-up

    Death due to any cause

  4. Number of participants who have a cardiovascular death

    Time frame: From time of CTCA scan to 36- and 60-months follow-up

    Death due to a cardiovascular cause (including myocardial infarction, heart failure, stroke, or any other cardiovascular disease)

Other outcomes

  1. Number of participants who suffer a clinically significant acute kidney injury following study CTCA scan

    Time frame: From time of CTCA scan to 28 days follow-up

    Unexpected progression to dialysis (haemodialysis or peritoneal dialysis) within 28 days of study CTCA scan

  2. Number of participants who have clinically significant abnormal non-cardiac findings on study CTCA scan

    Time frame: From time of CTCA scan to 12 months follow-up

    Abnormal non-cardiac findings (e.g., lung mass), not related to a pre-existing condition and requiring further investigation

Study contacts

Contact information is provided by the study sponsor or research team.

Gavin B Chapman, MBChB

CONTACT

[email protected]

00447713349318

Neeraj Dhaun, MBChB

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • NHS Greater Glasgow and Clyde
  • NHS Lothian
  • University of Glasgow

Registry information

Acronym: CRAFT-CTCA

Important dates

Study start
2024
Primary completion
2032
Study completion
2032
First posted
Jan 31, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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